Food Safety Modernization Act (FSMA) Key Themes/Concepts

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Food Safety Modernization Act (FSMA) Key
Themes/Concepts

• Jeannie Perron, JD, DVM
• Covington Burling LLP

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Food Safety Modernization Act (FSMA) Key
Themes/Concepts

• Focus on prevention, not inspection/ testing
• Risk-based approach

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Food Safety Modernization Act (FSMA) Key
Themes/Concepts

• Supply chain traceability/ transparency
• Know your supplier, particularly for imports

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Food Safety Modernization Act (FSMA) Key
Themes/Concepts

• Enable food safety crises rapid response,
  containment
• Enhance FDAs inspection/ enforcement authority

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Hazard Analysis

• Must identify/evaluate known or reasonably
  foreseeable hazards
• biological, chemical, physical, radiological
  hazards natural toxins pesticide and drug
  residues unapproved food/color additives
  allergens
• hazards naturally occurring or intentionally
  introduced

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Hazard Analysis

• Reanalyze every 3 years or whenever a significant
  change is made affecting risk

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Preventive Controls

• Identify and implement preventive controls
• to significantly minimize or prevent identified
  hazards and
• so undeclared allergens will not adulterate or
  misbrand food

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Preventive Controls

• Must monitor and verify that preventive controls
  are effective, and take corrective action when
  needed
• Verification activities include environmental and
  product testing programs
• Must keep records of these activities for 2
  years, including test results

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Preventive Controls

• Preventive controls are
• Risk-based procedures, practices, and processes
• That a knowledgeable person would employ
• Consistent with current scientific understanding
  of safe food manufacturing/ handling

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Preventive Controls

• Examples include
• Sanitation procedures and practices
• Process pathogen controls
• Allergen control program
• Recall plan
• Current good manufacturing practices (cGMPs)
• Verification procedures for suppliers and
  incoming ingredients

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Preventive Controls FDA Regulatory
Implementation

• Hazard analysis/preventive controls requirements
  effective July 2012
• Statute says FDA must promulgate regulations by
  then that
• establish science-based minimum standards for
• analyzing and documenting hazards
• implementing and documenting preventive controls
• work for all sizes and types of facilities

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Preventive Controls FDA Regulatory
Implementation

• FDA may exempt from hazard analysis/preventive
  control requirements facilities solely engaged in
  the storage of packaged foods that are not
  exposed to the environment

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Traceability

• By Jan. 2013, FDA must require additional
  recordkeeping for high risk foods

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Foreign Supplier Verification Program

• U.S. importers must have a program by January
  2013 to verify that imported food is produced in
  accordance with U.S. requirements

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Foreign Supplier Verification Program

• FDA must promulgate guidance and regulations
  within 1 year, and may require
• monitoring records for shipments
• lot-by-lot certification of compliance
• annual on-site inspections
• checking the hazard analysis and preventative
• controls of the foreign supplier, and
• periodically testing and sampling shipments

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Expanded FDA Records Access

• FDA records access authority expanded to foods
  FDA believes likely to be affected in a similar
  manner
• FDA will have access to all newly-required
  records (including test results)

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Facility Registration Changes

• Biennial registration
• No registration fee
• Bill does contain fees for reinspection and
  reimbursement of FDAs recall-related expenses

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Facility Registration Changes

• Suspension of registration
• If FDA determines that a food manufactured,
  processed, received, or held by a registered
  facility has a reasonable probability of causing
  serious adverse health consequences or death, may
  suspend
• If suspended, food from facility may not be
• introduced into commerce

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FDA Inspection/Enforcement

• Increased inspection schedule
• Hi-risk facilities
• Once during first 5 years after enactment
• Every 3 years thereafter
• Other facilities
• Once during first 7 years after enactment
• Every 5 years thereafter

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FDA Inspection/Enforcement

• FDA mandatory recall authority for Class I
  recalls
• Relaxed standards for administrative
• detention
• reason to believe food is adulterated or
  misbranded